Question 1

Who is the manufacturer of ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)?

Accepted Answer

Roche Diagnostic Systems, Inc. filed the 510(k) submission for ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) (K895906).

Question 2

What is the FDA product code for ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)?

Accepted Answer

LCM. as a Class U device in the TX panel.

Question 3

When was ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP) cleared by the FDA?

Accepted Answer

Jan 26, 1990 (decision: SESE).

Question 4

What is the regulatory pathway for ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K895906
Device Name	ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)
Applicant	Roche Diagnostic Systems, Inc.
Product Code	LCM · TX
Decision Date	Jan 26, 1990
Decision	SESE
Submission Type	Traditional
Device Class	Class U

ABUSCREEN ONTRAK FOR PHENCYCLIDINE (PCP)

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